Phase III

Cardiovascular

pain 72#18volume 2,125#8

Pain rank 18 of 76, volume rank 8 of 76 by industry trials. Trials here amend about 1.4x and fail enrollment about 1.1x the map median.

What this is worth

The amendment proxy, priced. Order of magnitude, anchor cited, assumptions on the table.

Per 100 industry trials in this cell, about 58 rewrite their eligibility criteria at least once. At the industry average of $450k direct cost per amendment, with the 6+ weeks of delay each not even counted, that is at least $26M at stake per 100 trials. Across the roughly 2,125 industry trials here, the floor is $558M.

If amendments fell by10%$56M30%$167M50%$279M

Assumes $450k direct cost per amendment (industry average; Phase II median runs lower, Phase III higher, and delay cost is excluded), applied to the proxy rate. The proxy counts only trials with at least one eligibility change, so this understates the true exposure. How this is derived.

The signals

Industry sponsors first, since that is the commercial buyer, each figure shown against the map median. All-sponsor figures follow. A trial counts as concluded once it has finished, whether completed, terminated or withdrawn.

Industry sponsors72pain index
Eligibility amendments
58%vs map 40%proxyn = 48sampled
Enrollment failure
14%vs map 13%n = 1,777concluded
Startup lag
56 dvs map 45.5 dn = 1,031with dates
Median duration
20.2 mon = 1,956completed
All sponsors61pain index
Eligibility amendments
41%proxyn = 91sampled
Enrollment failure
16%n = 3,153concluded
Startup lag
73 dn = 1,977with dates
Median duration
24.0 mon = 3,863completed
Why these trials stoppedsponsor decision leads

The most common category here is sponsor decision (62 of 257 stopped). A keyword pass runs first; free text it could not place was sorted once by a frozen AI classification into these same categories, auditable rather than a live model. "No enrollment recorded (inferred)" is not a stated reason: it is read from a zero enrollment count, meaning the trial never enrolled anyone. "Not reported" means the sponsor left the field blank, shown rather than hidden.

Sponsor decision62 (24%)
Efficacy or futility51 (20%)
Not reported45 (18%)
Low accrual32 (12%)
Safety or tolerability20 (8%)
No enrollment recorded (inferred)inferred14 (5%)
Logistics or operations5 (2%)
External or regulatory5 (2%)
Other stated reason4 (2%)
Change in standard of care4 (2%)
Superseded by another study3 (1%)
Never initiated3 (1%)
Technical or device issue3 (1%)
Business or funding2 (1%)
Completed or objective met2 (1%)
Feasibility or operational failure2 (1%)
n = 257terminated or withdrawn
Evidence12 trials

A sample of terminated or withdrawn trials in this cell. Each links to its ClinicalTrials.gov record.

TrialSponsorStatusStated reason
NCT05557942Aerovate TherapeuticsterminatedEfficacy or futility
NCT05347147Invex Therapeutics Ltd.terminatedFeasibility or operational failure
NCT05253209Asklepion Pharmaceuticals, LLCterminatedEfficacy or futility
NCT05195827PRM Pharma, LLCwithdrawnSponsor decision
NCT05144360EMSwithdrawnSponsor decision
NCT05126966Hoffmann-La RochewithdrawnEfficacy or futility
NCT05039359InCarda Therapeutics, Inc.terminatedEfficacy or futility
NCT05036135Aerovate TherapeuticsterminatedEfficacy or futility
NCT04970108EMSwithdrawnSponsor decision
NCT04857840Quantum Genomics SAterminatedEfficacy or futility
NCT04811092Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USAterminatedChange in standard of care
NCT04757636Opthea LimitedterminatedEfficacy or futility

Cardiovascular at other phases